Regulatory Affairs Specialist
Global Medical Device Company – Yokneam
Hybrid: 3 days onsite, 2 days from home
We are seeking a Regulatory Affairs Specialist to join a leading global medical device company. This role includes ownership of regulatory submissions, technical documentation, and change management within multidisciplinary systems involving hardware, software, and invasive medical technologies.
What You’ll Do
* Lead end-to-end regulatory submissions, including technical documentation, change submissions, and authoring regulatory files for global markets.
* Manage regulatory aspects of design and manufacturing changes, including impact assessments on global approvals.
* Develop regulatory strategies for the US and EU markets.
* Collaborate directly with regulatory authorities, including regular interactions with US (FDA) and European agencies.
* Work closely with internal cross-functional teams-R&D, Operations, Quality, Engineering-as well as external partners.
* Participate in discussions with development and operations teams regarding new products and ongoing changes.
* Occasionally participate in evening calls with US-based teams.
* Work in a hybrid model: 3 days in the Yokneam office, 2 days from home.
Requirements
* Minimum 4 years of experience in Regulatory Affairs in the medical device industry (not pharma).
* Experience with multidisciplinary systems (hardware, software, invasive devices).
* Strong independent work style, fast execution, and assertiveness.
* Excellent command of English—both written and spoken.
* Proven experience in authoring technical regulatory documents and leading submissions.
* Motivation to grow and remain in the role for several years.
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